FDA WARNING_LETTER - RadLogics, Inc.

On April 5, 2018, the FDA issued a Warning Letter to RADLogics, Inc. for marketing its AlphaPoint Imaging Software without required marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act. The FDA determined AlphaPoint is an adulterated device under section 501(f)(1)(B) and misbranded under section 502(o) of the Act.

AlphaPoint was cleared under K120161 for basic image review and analysis. However, RADLogics' website and YouTube video (published November 21, 2017) promote the software as providing computer-assisted detection (CADe) functionality, utilizing machine learning to automatically detect and mark abnormalities like lung nodules, pneumothorax, and pleural effusion. Promotional materials describe AlphaPoint as a "Virtual Resident" that performs initial image review and generates reports, suggesting it can replace or significantly reduce a physician's diagnostic task.

These promotional claims constitute a major change to the device's intended use, requiring a new premarket submission (PMA or 510(k)). The FDA noted that RADLogics previously acknowledged this in 2016 and temporarily removed such content, but has since reactivated it. The lack of evidence supporting the safety and efficacy of AlphaPoint's CADe capabilities raises public health concerns, including risks of false positives (unnecessary biopsies/surgeries) and false